Crysvita Severe Hypercalcemia Risk Communication
Summary
Swissmedic, in coordination with Kyowa Kirin, issued a Direct Healthcare Professional Communication (DHPC) warning of severe hypercalcemia risk associated with Crysvita (Burosumab). Cases of elevated serum calcium, including life-threatening hypercalcemia, have been reported, particularly in patients with tertiary hyperparathyroidism. The communication establishes contraindications for patients with moderate to severe hypercalcemia (>3.0 mmol/L) and provides updated monitoring protocols.
What changed
Swissmedic has issued a safety communication regarding Crysvita (Burosumab) following reports of severe hypercalcemia, including cases in patients with tertiary hyperparathyroidism. The DHPC establishes that Burosumab should not be administered to patients with moderate to severe hypercalcemia (>3.0 mmol/L) until the condition is adequately managed. Healthcare professionals must implement enhanced monitoring including serum calcium assessments before treatment initiation, 1-2 weeks after starting or adjusting dosage, then every 6 months (every 3 months for children aged 1-2 years), along with parathyroid hormone monitoring at the same intervals.
Healthcare providers prescribing or administering Burosumab should immediately review the DHPC and update clinical protocols to include the new contraindications and monitoring requirements. Pharmacies should ensure prescribing clinicians are aware of the hypercalcemia risk factors (hyperparathyroidism, prolonged immobilization, dehydration, hypervitaminosis D, renal impairment). Patient counseling should address recognition of hypercalcemia symptoms. The communication takes effect April 1, 2026.
What to do next
- Review DHPC and update clinical protocols for Burosumab monitoring to include serum calcium before treatment, 1-2 weeks after initiation/adjustment, and every 6 months (children 1-2 years: every 3 months)
- Implement contraindications: do not administer Burosumab to patients with moderate to severe hypercalcemia (>3.0 mmol/L) until resolved
- Assess all current patients for hypercalcemia risk factors including hyperparathyroidism, immobilization, dehydration, hypervitaminosis D, and renal dysfunction
Archived snapshot
Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
DHPC – Crysvita (Burosumab)
Risiko einer schweren Hyperkalzämie
01.04.2026
In Abstimmung mit Swissmedic möchte Sie Kyowa Kirin über wichtige Informationen zur Sicherheit bei der Anwendung von Burosumab informieren:
Zusammenfassung
- Bei Patienten, die mit Burosumab behandelt wurden, wurde über einen Anstieg des Serumkalziums, einschliesslich schwerer Hyperkalzämie, und/oder des Parathormons berichtet.
- Insbesondere bei Patienten mit tertiärem Hyperparathyreoidismus wurde über schwere Hyperkalzämie berichtet.
- Bei Patienten mit moderater bis schwerer Hyperkalzämie (> 3,0 mmol/l) sollte Burosumab nicht verabreicht werden, bis die Hyperkalzämie angemessen behandelt wurde.
- Die Überwachung von Patienten, die mit Burosumab behandelt werden, sollte Folgendes umfassen:
- Serumkalzium vor Beginn der Behandlung, 1–2 Wochen nach Behandlungsbeginn und nach Dosisanpassungen sowie während der Behandlung alle 6 Monate (alle 3 Monate bei Kindern im Alter von 1–2 Jahren),
- Parathormon alle 6 Monate (alle 3 Monate bei Kindern im Alter von 1–2 Jahren).
- Faktoren wie Hyperparathyreoidismus, längere Immobilisation, Dehydratation, Hypervitaminose D oder Nierenfunktionsstörungen können das Risiko einer Hyperkalzämie erhöhen. Detaillierte Informationen dazu können dem PDF-Dokument entnommen werden.
- Company information letter
DHPC – Crysvita (Burosumab) (PDF, 260 kB, 31.03.2026)
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